Editorial: What CORR ® Seeks From Papers About New Implants and Techniques

摘要

Orthopaedic surgery is a humane profession, but one that relies on physical technology. While greater attention has been given of late to more holistic, patient-centered approaches, many outside the field perceive orthopaedic surgeons as “tool people,” and some of us likely would endorse that characterization ourselves. It is therefore perhaps unsurprising that as a group, we remain overrepresented relative to other medical and surgical specialties in terms of relationships with the industry partners that design our implants, instruments, and devices [8]. In the only survey we could find on the topic, orthopaedic surgeons consistently ranked implant design, biomaterials, and instrumentation as more important to the success of an arthroplasty procedure than the patient, the team, or the surgeon [3]. Small wonder that our journals are full of articles evaluating the efficacy of the tools we use. But too often, journals allow authors to share overly enthusiastic messages too early in our collective experience with new tools, approaches, and devices. To be clear, Clinical Orthopaedics and Related Research® is interested in reporting on the performance of devices that are emerging as well as those that are in common use. But as we do so, we apply specific standards. Unintended consequences arising from well-meaning changes in practice have led to devastating public health harms in the past, and likely will do so again unless journals adopt and maintain thoughtful standards. Here are ours: First, all studies we publish that make claims about treatments must have a specific, usable clinical message that can improve patient care, practice management, or healthcare policy and resource allocation. This standard, of course, is not a new one for us. However, as we evaluate those studies’ claims, we will insist that studies evaluating a newer biomaterial or implant not support its adoption in clinical practice unless it is better in ways that patients can perceive than are available, well-performing alternatives that have been in use for a longer time. Of course, a different standard applies when assessing interventions for which there are no options or no good ones, and we’ll come to that standard in a moment. But where good and time-tested implants, biomaterials, surgical approaches, or tools exist, novel ones that are “as good as” or “comparable to” won’t make the grade if there is robust evidence demonstrating that the tried-and-true generally performs well. There are several reasons for this. The main ones are that new devices and biomaterials usually are more expensive than established ones, they generally come with learning curves during which patients may be harmed, and they always carry safety-related uncertainties associated with novelty. We’ve all seen too many devices and materials that look good early become problematic later on. Modesty calls on us to remember this when reporting on new things. We’ll hold authors to these expectations until the new device is found superior at sufficiently long surveillance periods as appropriate for the device in question, or until equivalence is shown at longer-term follow-up and the new device is less expensive. Of course, such guidelines will be applied thoughtfully. For example, there may be subsets of patients who don’t do well with a particular treatment even when most do; imagine a new biomaterial that can mitigate hypersensitivity reactions in patients known to be at risk for them, and the implant made of that newer biomaterial is as good as but no better than one made from the more-established biomaterial. In that instance, it might be sensible to recommend use of the new biomaterial when treating patients with hypersensitivity, but not recommend wider adoption beyond that. And occasionally, a new approach seems to work as well as more-established alternatives but is less expensive. In such circumstances, authors are free to describe a risk/reward proposition if they think the result